Protogyn Tablets
Tinidazole
500mg
HAYAT PHARMACEUTICAL INDUSTRIES CO. LTD.
| Pack size | 4's Blister |
|---|---|
| Dispensing mode | POM |
| Source | JORDAN |
| Agent | NEW MEDICAL CENTRE |
| Retail Price | 12.00 AED |
Indications
Protogyn Tablets is used for:
Giardiasis, H. pylori infection, Surgical Prophylaxis, Bacterial vaginosis, Intestinal amoebiasis, Trichomoniasis, Acute necrotising ulcerative gingivitis, Hepatic amoebiasis
Adult Dose
Oral
Bacterial vaginosis
Adult: 2 g as single dose. May also be given as 2 g for 2 consecutive days or 1 g daily for 5 days.
Anaerobic bacterial infections
Adult: 2 g on the 1st day, followed by 1 g daily or 500 mg bid for 5-6 days.
Prophylaxis of postoperative anaerobic bacterial infections
Adult: 2 g as single dose 12 hr before surgery.
Eradication of H. pylori associated with peptic ulcer disease
Adult: 500 mg bid, given w/ clarithromycin and omeprazole for 7 days.
Intestinal amoebiasis
Adult: 2 g daily for 2 or 3 days.
Hepatic amoebiasis
Adult: 1.5-2 g daily for 3-6 days.
Giardiasis
Adult: 2 g as single dose.
Trichomoniasis; Acute necrotising ulcerative gingivitis
Adult: 2 g as single dose. In trichomoniasis, sexual partners should be treated at the same time.
Intravenous
IV Susceptible infections
Initial: Infuse 800 mg, followed by 800 mg/day or 400 mg twice daily till PO can be given.
Surgical prophylaxis
1.6 g as single infusion pre-op.
Child Dose
Oral
Intestinal amoebiasis
Child: >3 yr 50-60 mg/kg daily for 3 consecutive days. Max: 2 g/day.
Hepatic amoebiasis
Child: >3 yr 50-60 mg/kg daily for 5 days. Max: 2 g/day.
Giardiasis
Child: >3 yr 50-75 mg/kg as single dose, repeat if necessary. Max: 2 g/day.
Renal Dose
Renal impairment: Haemodialysis: Additional dose equal to half the usual dose at the end of haemodialysis.
Administration
Should be taken with food. Take during or immediately after meals.
Contra Indications
Blood dyscrasias, organic neurologic disorders, hypersensitivity to 5-nitroimidazole derivatives, porphyria. Lactation, pregnancy (1st trimester).
Precautions
Patient w/ current or a history of blood dyscrasias. Pregnancy (2nd and 3rd trimester). Hepatic and renal impairment. Monitoring Parameters Monitor total and differential leukocyte counts. Closely monitor childn when treatment duration exceeds 3 days.
Lactation: discontinue nursing while taking drug & for 3 d after last dose
Pregnancy-Lactation
Pregnancy
Available published data from a case-control study and case report with use in pregnant women are insufficient to identify risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; there are risks associated with untreated lower genital tract infections during pregnancy
Infertility
Based on findings in rodents, therapy may impair fertility in males of reproductive potential; not known whether effects on fertility are reversible
Animal data
In animal reproduction studies, oral administration of tinidazole to pregnant mice and rats during organogenesis at 6 and 3 times, respectively, the maximum recommended human dose (based on body surface area comparison) showed a slight increase in fetal mortality in rats at highest dose, with no other adverse fetal effects noted in either species
Lactation
Limited published literature, based on breast milk sampling, reports that drug is present in human milk; there are no reports of adverse effects on breastfed infant and no information on effects on milk production
Because of potential for serious adverse reactions, including tumorigenicity, breastfeeding is not recommended during treatment and for 72 hours (based on half-life) after last dose
A nursing mother may choose to pump and discard her milk during treatment and for 72 hours after last dose to minimize exposure to breastfeeding infant
Interactions
May potentiate the effects of oral anticoagulants resulting to prolonged prothrombin time.
Adverse Effects
Side effects of Tinidazole :
1-10%
Anorexia (2-3%), Constipation (<1%), Dizziness (<1%), Dysgeusia (4-6%), Dyspepsia (1-2%), Headache (<1%), Nausea (3-5%), Vomiting (1-2%), Weakness/fatigue/malaise (1-2%)
Frequency Not Defined
Ataxia, Candida overgrowth, Convulsions & transient peripheral neuropathy, Numbness & paresthesia, Diarrhea, Darkened urine, Tongue discoloration, Transient leukopenia/neutropenia
Potentially Fatal: Hypersensitivity.
Mechanism of Action
Tinidazole, a 5-nitroimidazole derivative w/ antimicrobial actions similar to metronidazole, is active against both protozoa (e.g. Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia) and obligate anaerobic bacteria. It damages DNA strands or inhibits DNA synthesis in microorganism.
Note
Protogyn 500mg Tablets manufactured by HAYAT PHARMACEUTICAL INDUSTRIES CO. LTD.. Its generic name is Tinidazole. Protogyn is availble in United Arab Emirates.
Farmaco UAE drug index information on Protogyn Tablets is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.